Clinical Trial: Pilot Study of Positive-End Expiratory Pressure in Acute Respiratory Distress Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Controlled Pilot Study of Positive End-Expiratory Pressure (PEEP) in Acute Respiratory Distress Syndrome(ARDS): Individualized According to the Best Compliance

Brief Summary: Randomized controlled pilot trial in 70 patients with Acute Respiratory Distress Syndrome (ARDS) ventilated with low tidal volumes and limitation on airway pressure at 35 centimeters of water (cmH2O), to compare two different methods of selecting the level of Positive End-Expiratory Pressure (PEEP) to be applied: according to fraction of inspired oxygen (FiO2) needed or individualized according to the best compliance. Primary objective was evolution of arterial oxygenation during the 28 days. Secondary objectives were to measure its effects on hemodynamic parameters, 28-day mortality, number of ventilator-free days at day 28, Intensive Care Unit (ICU) and hospital stay, number of multiple-organ dysfunction-free days and a multivariate analysis of 28 day-mortality.

Detailed Summary:

In patients with Acute Respiratory Distress Syndrome the use of Positive End-Expiratory Pressure (PEEP) avoids atelectrauma, improves gas exchange and induces alveolar recruitment.Although it has side effects as inducing alveolar overdistension and circulatory depression.

There are several methods to determine the level of PEEP to be applied. We conducted a study to test the hypothesis that an individualized level of PEEP, set et the best compliance, when compared with a fixed level according to the fraction of inspired oxygen applied, improves oxygenation and reduces mortality rate at 28 days.


Sponsor: Hospital Universitario Principe de Asturias

Current Primary Outcome: Arterial Oxygenation [ Time Frame: 28 days ]

Evolution of arterial oxygenation during the 28 days after study randomization


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mortality [ Time Frame: 28 days ]
    Mortality 28 days after randomization
  • Number of ventilator-free days at day 28 [ Time Frame: 28 days ]
    Number of ventilator-free days at day 28 after randomization
  • multivariate analysis of mortality [ Time Frame: 28 days ]


Original Secondary Outcome: Same as current

Information By: Hospital Universitario Principe de Asturias

Dates:
Date Received: May 6, 2010
Date Started: January 2003
Date Completion:
Last Updated: May 7, 2010
Last Verified: December 2002